Ultrasonographic Evaluation of Cosmetic Keratolytic Treatment of Foot Calluses and Corns
10. august 2026 opdateret af: Agnieszka Ciszek, Wroclaw University of Health and Sport Sciences
Ultrasonographic Evaluation of Cosmetic Keratolytic Treatment of Hyperkeratotic Foot Lesions: A Prospective, Non-randomized, Controlled, Comparative Study of Calluses and Corns
This prospective, non-randomized, controlled study evaluated the efficacy of a topical cosmetic keratolytic preparation (serum and cream containing urea, salicylic acid, and collagen) in reducing the thickness and associated pain of hyperkeratotic foot lesions (calluses and corns).
High-frequency ultrasonography (18 MHz) was used for precise, quantitative measurement of lesion thickness before and after a two-month intervention.
Participants were allocated to four parallel groups (treated calluses, untreated callus controls, treated corns, and untreated corn controls).
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
A total of 124 women aged 35-65 years, each presenting with a single non-infectious hyperkeratotic foot lesion, were allocated by lesion type (callus or corn) and by intervention (treated vs untreated), forming four parallel groups of 31.
Treated participants applied 2 mL of serum followed by 2 mL of cream, each massaged into the lesion for two minutes, twice daily for two months.
Untreated controls received no topical intervention over the same period.
Lesion thickness (cm) was measured with an Esaote MyLab60 system and an 18 MHz linear probe, and pain was self-reported on a 0-10 visual analogue scale, at baseline and after two months.
Within-group changes were analysed with the Wilcoxon signed-rank test and between-group reductions with the Mann-Whitney U test.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
124
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
-
Swidnica, Polen
- OSTEON Clinic
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-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
Inclusion Criteria:
- Adult women aged 35-65 years.
- Presence of a single non-infectious hyperkeratotic foot lesion classified as either a callus or a corn.
- Written informed consent provided prior to study initiation.
Exclusion Criteria:
- Known allergy or hypersensitivity to salicylic acid, salicylates, or other formulation ingredients.
- Active dermatological conditions, skin diseases, or epidermal fissures on the lower extremities.
- Diabetes mellitus.
- Active cardiovascular disorders or local inflammatory conditions.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Calluses: Keratolytic Treatment
Women with foot calluses applying the topical keratolytic cosmetic serum and cream twice daily for 2 months.
|
Application of 2 mL serum followed by 2 mL cream containing urea, salicylic acid, and collagen, massaged into the hyperkeratotic lesion for 2 minutes, twice daily (morning and evening) for 2 months
|
|
Ingen indgriben: Calluses: Untreated Control
Women with foot calluses receiving no topical treatment over the 2-month observation period
|
|
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Eksperimentel: Corns: Keratolytic Treatment
Women with foot corns applying the topical keratolytic cosmetic serum and cream twice daily for 2 months
|
Application of 2 mL serum followed by 2 mL cream containing urea, salicylic acid, and collagen, massaged into the hyperkeratotic lesion for 2 minutes, twice daily (morning and evening) for 2 months
|
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Ingen indgriben: Corns: Untreated Control
Women with foot corns receiving no topical treatment over the 2-month observation period
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change in Hyperkeratotic Lesion Thickness
Tidsramme: Baseline and 2 months
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Lesion thickness measured in centimetres using high-frequency ultrasonography (Esaote MyLab60 with an 18 MHz linear probe)
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Baseline and 2 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change in Lesion-Associated Pain
Tidsramme: Baseline and 2 months
|
Participant self-reported pain assessed on a Visual Analogue Scale (VAS) from 0 (no pain) to 10 (worst imaginable pain).
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Baseline and 2 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 1. Wortsman, X. Expanding dermatologic ultrasonography applications: further insights for enhanced patient management. Ultrasonography 42 (3), 476-477. https://doi.org/10.14366/usg.23082 (2023). 2. Bader, D. & Worsley, P. Technologies to monitor the health of loaded skin tissues. Biomed. Eng. Online 17 (1), 40-59. https://doi.org/10.1186/s12938-018-0457 (2018). 3. Benedetti, J. Diagnostic tests for skin disorders. MSD Manual Professional Edition (2024). 4. National Institute of Biomedical Imaging and Bioengineering. Ultrasound. NIBIB (Bethesda, MD). 5. Bhatta, A. et al. Application of high-frequency ultrasound in dermatology. Discov. Med. 26 (145), 237-242 (2018). 6. Cheng, X. et al. High-frequency ultrasound in blistering skin diseases: a useful method for differentiating blister locations. J. Ultrasound Med. 36 (11), 2367-2371. https://doi.org/10.1002/jum.14302 (2017). 7. Cohen, P. R. & Anderson, C. A. Topical selenium sulfide for the treatment of hyperkeratosis. Dermatol. Ther. (Heidelb.) 8 (4), 639-646. https://doi.org/10.1007/s13555-018-0247-2 (2018). 8. Wortsman, X. Top applications of dermatologic ultrasonography that can modify management. Ultrasonography 42, 183-202. https://doi.org/10.14366/usg.22130 (2023). 9. Argalia, G. et al. High-frequency and ultra-high-frequency ultrasound in dermatologic diseases and aesthetic medicine. Medicina (Kaunas) 61 (2), 220. https://doi.org/10.3390/medicina61020220 (2025). 10. Cisoń, H. & Białynicki-Birula, R. High-frequency ultrasonography: one of the modern imaging diagnostic methods in dermatology. Authors' own experience and review. Adv. Dermatol. Allergol. 41 (3), 306-313. https://doi.org/10.5114/ada.2024.141108 (2024). 11. Wang, Q. et al. Role of high-frequency ultrasound in differentiating benign and malignant skin lesions: potential and limitations. Ultrasonography 43 (4), 238-249. https://doi.org/10.14366/usg.24015 (2024). 12. Jaguś, D., Malinowska, S. & Mlosek, R. Skin ultrasound diagnostics in beauty parlour. Ae
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. februar 2020
Primær færdiggørelse (Faktiske)
1. marts 2026
Studieafslutning (Faktiske)
1. maj 2026
Datoer for studieregistrering
Først indsendt
10. august 2026
Først indsendt, der opfyldte QC-kriterier
10. august 2026
Først opslået (Faktiske)
14. august 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
14. august 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
10. august 2026
Sidst verificeret
1. august 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- KEBN-23-02-14
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
De-identified individual participant data (lesion thickness measurements and VAS pain scores, before and after the intervention) underlying the results reported in the associated publication will be made available.
IPD-delingstidsramme
Beginning after publication of the main results, with no planned end date
IPD-delingsadgangskriterier
Available to qualified researchers on reasonable request to the corresponding author (agnieszka.ciszek@awf.wroc.pl)
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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